I Advice - Insurance

Within the Golden State that is California, all is not necessarily golden in terms of who does and

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

does not have health insurance.

California is one of the most populous states in the nation. Acc

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ording to the United States Census Bureau, it is home to well over 30 million people of all racial

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

and ethnic backgrounds. But regardless of their age or the language they speak each of them has on

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

e thing in common they all need health insurance.

There are many ways for California residents to

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

obtain health insurance. Some are eligible to participate in group health insurance plans sponsore

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

d by their employers. Others purchase individual health insurance for themselves and their familie

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

s. Low-income individuals are often eligible for Medicaid, and seniors for Medicare. Both these go

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ernment-sponsored programs are designed to protect the most vulnerable Americans from having to de

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

al with healthcare costs on their own.

Being uninsured leads to higher healthcare costs in the lo

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

g run because conditions and problems that could be easily cured or arrested with early detection

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

often go undiagnosed because people can't afford to visit their doctor.

The Kaiser Family Foundat

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ion reports that there are around 6,448,540 uninsured Californians that is over 15 percent of the

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

tate's total population. Of those who are insured, the Foundation reports that over 2 million requ

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ire individual health insurance because they are not eligible for coverage through their employer

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

r through Medicaid or Medicare.

Even the over 8 million Californians who do qualify for Medicaid

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

or Medicare often require supplemental coverage. Many insurance companies offer programs specifica

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

lly designed to meet the requirements of people who want or need more coverage than Medicaid or Me

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

icare provides. For example, a senior might be interested in a program that includes discounts on

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

services such as vision check-ups and corrective lenses, dental care or even chiropractic services

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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I Advice - Uninsured vs Insured in California

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